Neuromuscular Electrical Stimulation (NMES) Preserves Muscle Mass in Intensive Care Unit (ICU)

Not Applicable

Completed

• Conditions: Physical Disability; Muscle Atrophy; Critical Illness
• Interventions: Other: Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.; Other: Patients received the low-frequency neuromuscular electrical stimulation (NMES); Other: Patients received the medium-frequency neuromuscular electrical stimulation (NMES)

• Registration Number: NCT05287919
• Lead Sponsor: Gabriel Nasri Marzuca-Nassr

Brief Summary

Background: Low-frequency neuromuscular electrical stimulation (NMES) attenuates the loss of muscle mass of Intensive Care Unit (ICU) patients. However, it has been shown that medium-frequency NMES may be better than low-frequency for the maintenance of skeletal muscle mass in healthy subjects.

Objective: to compare the effects of low-frequency and medium-frequency NMES, along with a standard physical therapy (SPT) programme, on the attenuation of skeletal muscle atrophy in critically ill patients.

Methods: Fifty-four critically ill patients admitted into intensive care unit (ICU) and on mechanical ventilation (MV) participated in this randomized, single-blinded, experimental study. Participants were allocated to one of the following groups: Control Group (CG), received a standard lower limb physical therapy (SPT) programme, 2x/day; Low-frequency NMES Group (LFG), received lower limb SPT+NMES at 100 Hz, 2x/day; and Medium-frequency NMES Group (MFG), received lower limb SPT+NMES at 100 Hz and carrier frequency of 2500 Hz, 2x/day. The primary outcome was the thickness and quality of the quadriceps muscle, evaluated with ultrasonography while patients were in ICU. Secondary outcomes, assessed at various stages of recovery, were strength, functionality, independence for activities of daily living, quality of life, and total days hospitalized.

Detailed Description

Background: Low-frequency neuromuscular electrical stimulation (NMES) attenuates the loss of muscle mass of Intensive Care Unit (ICU) patients. However, it has been shown that medium-frequency NMES may be better than low-frequency for the maintenance of skeletal muscle mass in healthy subjects.

Research question: The research question was is medium-frequency neuromuscular electrical stimulation (NMES) more effective than low-frequency NMES for the attenuation of skeletal muscle atrophy in critically ill patients?

Objective: To compare the effects of low-frequency and medium-frequency NMES, along with a standard physical therapy (SPT) programme, on the attenuation of skeletal muscle atrophy in critically ill patients.

Methods: Fifty-four critically ill patients admitted into intensive care unit (ICU) and on mechanical ventilation (MV) participated in this randomized, single-blinded, experimental study. Participants were allocated to one of the following groups: Control Group (CG), received a standard lower limb physical therapy (SPT) programme, 2x/day; Low-frequency NMES Group (LFG), received lower limb SPT+NMES at 100 Hz, 2x/day; and Medium-frequency NMES Group (MFG), received lower limb SPT+NMES at 100 Hz and carrier frequency of 2500 Hz, 2x/day. The primary outcome was the thickness and quality of the quadriceps muscle, evaluated with ultrasonography while patients were in ICU. Secondary outcomes, assessed at various stages of recovery, were muscle strength (MRC-SS), handgrip strength (dynamometry), functional status (FSS-ICU), degree of independence for activities of daily living (Barthel Index), functional mobility and dynamic balance (Timed Up and Go Test), quality of life (SF-36), and total days hospitalized.

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Study First Submitted: 2022-02-19
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-09
• Last Update Submitted: 2022-03-09
• Study First Posted: 2022-03-18
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• patients between 18-80 years old admitted in ICU with requirement of mechanical ventilation (MV) for longer than 72 h.

Exclusion Criteria

• non-sedated patients;
• spinal cord injury;
• cerebrovascular accident;
• patients with pacemakers;
• history of deep vein thrombosis;
• pregnancy;
• cardiac complications (history of myocardial infarction or congenital diseases);
• use of neuromuscular blockers;
• polytraumatized patients requiring tutor support.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium-frequency NMES group	Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.	Patients submitted to medium-frequency NMES and SPT twice a day.
Low-frequency NMES group	Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.	Patients submitted to low-frequency NMES and SPT twice a day.
Control group	Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.	Patients received the standard physical therapy (SPT) programme only (passive mobilization) twice a day.
Low-frequency NMES group	Patients received the low-frequency neuromuscular electrical stimulation (NMES)	Patients submitted to low-frequency NMES and SPT twice a day.
Medium-frequency NMES group	Patients received the medium-frequency neuromuscular electrical stimulation (NMES)	Patients submitted to medium-frequency NMES and SPT twice a day.

Primary Outcome Measures

Name	Time	Method
Change in thickness of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).	Day 1, Day 5, Day 9	Thickness of the quadriceps muscle via ultrasonography (mm).
Change in quality of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).	Day 1, Day 5, Day 9	Quality of the quadriceps muscle via ultrasonography by Heckmatt's rating scale.; Muscle quality was estimated by Heckmatt's rating scale, which scores the ultrasound images between 1-4: 1) normal echogenicity; 2) slight increase in muscle echogenicity and normal bone reflection; 3) moderate increase in muscle echogenicity and reduced bone reflection; 4) large increase in muscle echogenicity and no bone reflection.

Secondary Outcome Measures

Name	Time	Method
Change in Handgrip strength while patients were in hospital stay.	Day 9, Day 11, Day 16, and Day 27	Handgrip strength via digital dynamometer (kg).
Change in independence for activities of daily living while patients were in hospital stay.	Day 16, and Day 27	Independence for activities of daily living via Barthel index (points). A patient scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities.
Change in Clinical assessment of muscle strength while patients were in intensive care unit (ICU).	Day 9, Day 11, Day 16, and Day 27	Clinical assessment of muscle strength via Medical Research Council-Sum Score (MRC-SS) (points), which ranges from 0 (complete paralysis) to 60 (normal strength).
Change in Functional status while patients were in Intensive Care unit (ICU).	Day 9, Day 11, Day 16, and Day 27	Functional status via Functional Status Score for the Intensive Care Unit (FSS-ICU) (points). FSS-\]ICU FSS-ICU score has a range of 0-35 with higher score indicating better functional status.
Change in dynamic balance while patients were in hospital stay.	Day 16, and Day 27	Dynamic balance via Timed Up and Go Test (seconds).
Change in quality of life prior to hospital discharge.	Day 27	Quality of life via Short Form 36 (SF-36) (points). The score go from 0 to 100. Higher scores mean a better outcome.

Trial Locations

Locations (1)

Department of Internal Medicine, Faculty of Medicine, Universidad de La Frontera; 🇨🇱 Temuco, Chile